BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOK

    MDR report key: 1530957 · Received October 27, 2009

    Report

    Report Number
    2522801-2009-00031
    Event Type
    Other
    Date Received
    October 27, 2009
    Date of Event
    September 1, 2009
    Report Date
    October 26, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAR
    PMA / PMN Number
    K926168
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS ESTIMATED. AS NOTED: NO CULTURES OR SENSITIVITIES WERE PERFORMED FOR ANY OF THESE CASES TO CONFIRM THE INFECTION. METHOD - THE DEVICE WAS NOT RETURNED FOR EVALUATION. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD AND STERILITY RECORD WAS REVIEWED FOR ITEM REPORTED. NO PERTINENT FINDINGS WERE NOTED. (B)(4). ITEM # 786B, LOOK, 3-0 BBS, LOT# M181440.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. THE DOCTOR'S ASSISTANT STATED THAT NINE (9) PTS DEVELOPED INFECTION POST ROUTINE TOOTH EXTRACTIONS USING DENTAL SUTURE MATERIAL 3-0 BLACK BRAIDED SILK. THERE WERE NO CULTURES OR SENSITIVITIES PERFORMED. ALL OF THE PTS WERE TREATED WITH ORAL ANTIBIOTICS WHICH RESOLVED SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK SUTURE AND NEEDLE GAR SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) 786B M181440

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE.